Dental enamel compositions  with anti-inflammatory agents

ABSTRACT

Provided are methods and compositions relating to a dental composition more specifically to prepare the damaged dentin of the tooth prior to repair. The dental compositions include a bioactive glass and a non-aqueous solvent comprising an alcohol, anti-inflammatory and anti-pain reliver.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.

The research for the Patent “DENTAL ENAMEL COMPOSITIONS WITHANTI-INFLAMMATORY AGENTS” was not funded by any federally sponsoredresearch or development.

BACKGROUND OF THE INVENTION

The restoration of destroyed or decayed tooth structures can be achievedthrough the use of various materials including dental amalgams,composite resins, porcelain, or gold. One method used involves thesequential application of a dental adhesive followed by a dentalrestorative material to'the affected tooth structure. Often the affectedtooth structure is pretreated to improve the bonding of the adhesive tothe dentin or the enamel of the affected tooth structure. For example,the bonding process may include three steps: (1) etching with aninorganic or organic acid to remove surface contaminants and topartially demineralize the dentin matrix; (2) priming with a monomerthat can penetrate the collagen-rich network that remains after theetching step; and (3) application of an adhesive resin. The adhesiveresin is typically cured to bond to a dental resin composite.Additionally, tooth enamel is the first line of defense against hot,cold, sticky, and abrasive items. When tooth enamel wears down, it cancause tooth decay, exposing dentin and sensitive nerves in the pulp ofthe teeth, and causing the tooth to appear yellow in color. The enamelcan weaken with age. Also, a diet high in sugar content or acidity,and/or a history of acid reflux disease can result in enamel loss.

U.S. Pat. Application 200901977221, herein incorporated by referencedescribes dental bonding slurry and U.S. Pat. Application 20050142077,herein incorporated by reference describes the use of antimicrobialglass ceramic in dental care.

However, glasses having a bioactive and, also, sometimes antimicrobialeffect are described as bioglass in An Introduction to Bioceramics,World Scientific Publ. (Hensch and Wilson, 1993). Bioglass of this typeis distinguished by the formation of hydroxylapatite layers in aqueousmedia. Heavy metal free alkali and alkaline earth silicate glasseshaving antimicrobial properties are described in the applicationsDE-A-199 32 238 and DE-A-199 32 239, herein incorporated by reference inits entirety.

A glass powder that includes 40-60 weight-percent SiO₂, 5-30weight-percent Na₂O, 10-35 weight-percent CaO, and 0-12 weight-percentP2Os is known from U.S. Pat. No. 5,676,720 herein incorporated byreference in its entirety, a glass ceramic manufactured from a glass ofthis type of composition also being known. However, no information aboutthe crystal phase is given in U.S. Pat. No. 5,676,720.

U.S. Pat. No. 5,981,412, herein incorporated by reference in itsentirety describes a bioactive bioceramic for medical applicationshaving the crystalline phase Na2O.2CaO3SiO2. The crystallite size is 13μm. The ceramization is performed using tempering steps for nucleationand crystallization. The emphasis is on mechanical properties such asK1c. The crystal phase component is between 34 and 60 volume-percent.U.S. Pat. No. 5,981,412, herein incorporated by reference in itsentirety only describes a crystalline phase that is a high-temperaturephase and that only arises under the special conditions specified inthis publication. An application in the field of dental care is notdescribed.

The use of bioactive glasses for toothpaste and gels is described, forexample, in WO 97/27148, herein incorporated by reference in itsentirety. Inorganic non-metallic materials that contain calcium andphosphorus and lead to tooth remineralization through appropriate iondonations are known from U.S. Pat. Nos. 5,427768 and 5,208,167, hereinincorporated by reference in its entirety.

All the above publications and patents cited in this specification areherein incorporated by reference as if each individual publication orpatent were specifically and individually indicated to be incorporatedby reference and are incorporated herein by reference to disclose anddescribe the methods and/or materials in connection with which thepublications are cited.

However, the prior art does not solve the issues associated with thedentin and enamel reconstruction and due to inflammation, infection andthe slow assimilation of the bioglass into the dentin structure. Theinstant invention provides solutions to these issues.

None of the aforementioned references describes the use of bioactiveglass applied to the existing exposed dentin due to loss of enamel thatcauses the tooth to appear yellow. The use of bioactive glass will beshown to retard the effect of staining and provide a mechanism toenhance light reflection, so the tooth appears whiter than the nativedentin exposed due to enamel loss.

However, glasses having a bioactive and, also, sometimes antimicrobialeffect are described as bioglass in An Introduction to Bioceramics,World Scientific Publ. (Hensch and Wilson, 1993). Bioglass of this typeis distinguished by the formation of hydroxylapatite layers in aqueousmedia. Heavy metal free alkali and alkaline earth silicate glasseshaving antimicrobial properties are described in the applicationsDE-A-199 32 238 and DE-A-199 32 239, herein incorporated by reference inits entirety.

A glass powder that, includes 40-60 of the total weight percent is Si02,5-30 of the total weight percent is Na₂O, 10-35 of the total weightpercent is CaO, and 0-12 of the total weight percent is P₂O₅ is knownfrom U.S. Pat. No. 5,676,720 herein incorporated by reference in itsentirety, a glass ceramic manufactured from a glass of this type ofcomposition also being known. However, no information about the crystalphase is given in U.S. Pat. No. 5,676,720.

U.S. Pat. No. 5,981,412 are herein incorporated by reference in itsentirety describes a bioactive bioceramic for medical applicationshaving the crystalline phase Na₂O.2CaO.3SiO₂. The crystallite size is 13μm. The ceramization is performed using tempering steps for nucleationand crystallization. The emphasis is on mechanical properties such asK₁c. The crystal phase component is between 34 and 60 volume-percent.U.S. Pat. No. 5,981,412, herein incorporated by reference in itsentirety only describes a crystalline phase that is a high-temperaturephase and that only arises under the special conditions specified inthis publication. An application in the field of dental care is notdescribed. U.S. Pat. Application 200901977221, herein incorporated byreference in its entirety describes dental bonding slurry's and U.S.Pat. Application 20050142077, herein incorporated by reference in itsentirety describes the use of antimicrobial glass ceramic in dentalcare.

The use of bioactive glasses for toothpaste and gels is described, forexample, in WO 97/27148, herein incorporated by reference in itsentirety. Inorganic non-metallic materials that contain calcium andphosphorus and lead to tooth remineralization through appropriate iondonations are known from U.S. Pat. Nos. 5,427,768 and 5,268,167, hereinincorporated by reference in its entirety. U.S. Patent application2009/019722 describes a method and compositions relating to a dentalbonding slurry useful in bonding a dental resin composite hereinincorporated by reference in its entirety.

The use of the glasses cited above in the fields of dental care and/ororal hygiene do not identify the ability for the glass to be used toincrease the perception of whiteness of the tooth. Additionally, all theabove publications and patents cited in this specification are hereinincorporated by reference as if each individual publication or patentwere specifically and individually indicated to be incorporated byreference and are incorporated herein by reference to disclose anddescribe the methods and/or materials in connection with which thepublications are cited.

The instant invention solves the problems of using peroxides by creatinga dental bonding slurry formed from bioactive glass and a suitablenon-aqueous solvent, for the first time, an effective dental bondingmethod is provided that does not utilize excessive bleaching or containsa large concentration of hydrogen peroxide.

The instant invention also provides a means of mitigating the pain anddiscomfort associated with the process of repairing and dental bondingthe dentin as well as a method to reduce the discomfort and pain to theindividual, reduce inflammation, infection and assist in bone resorptionfrom bone loss.

SUMMARY OF THE INVENTION

The disclosure provides methods and compositions relating to a dentalbonding slurry useful in bonding a dental resin composite. Teeth areprotected by enamel, their first defense against hot, cold, sticky, andabrasive items. When enamel wears down, it can cause tooth decay,exposing dentin and sensitive nerves within the pulp of the teeth, andcauses the tooth to look yellow. Enamel can become weaker with age, anacidic or sugary diet, and/or a history of acid reflux disease.Additionally, dentin hypersensitivity is observed after periodontaltreatment in periodontitis patients. The invention focuses on thedentinal tubule, one of the very small tubes or canals in the dentin.These tubules are responsible for dentin hypersensitivity. The dentintubules extend from the pulp cavity of the tooth to the enamel and areoccupied by odontoblastic processes and occasional nerve filaments. Inaddition to occluding the dentin tubule with a micro-mechanical bond theinvention discloses a means to increase the strength of thehydroxyapatite on surface of the tooth enamel and increase the fluidityflow of the slurry/gel into the dentin to create a much stronger bondand prevent microleakage/sensitivity. It is long known that the bioglasscan, in the aqueous presence of calcium and phosphate, form apatite tofurther prevent sensitivity and lock out micro-leakage through thetubules. However, the time for the calcium and phosphate apatite to forma bond is an issue with the patient acceptance of the treatment.

In addition to occluding the dentin tubule with a micro-mechanical bond,it is long known that the bioglass can, in the aqueous presence ofcalcium and phosphate, form apatite to further prevent sensitivity andlock out micro-leakage through the tubules and increase the appearanceof whiter enamel structure. However, the process can result in pain forthe patient and a method is needed to minimize the pain. To mitigate thepain the instant invention primary therapeutic ingredients, use acombination of natural products designed to reduce the problems withinflammation and pain as well as aspirin, or acetylsalicylic acid (ASA)which is a known anti-inflammatory and pain reliever. The naturalproducts include Neem or Nimba, Punica granatum, Menta spp. clove oil,Cannabidiol (CBD) oil, Boswellia and chlorotoxin and other inflammationand pain agents. By adding these treatment agents to the suspension ofthe instant invention the result is minimization of pain and discomfortassociated with the exposed dentin and with the process of repair anddental bonding the dentin.

Neem or Nimba leaf extract is used for gum disease (gingivitis), killbacteria and prevent plaque formation in the mouth.

Punica granatum (Pomegranate) is one of the oldest edible fruit whichhas a long history as a medicinal fruit. Punica granatum has apreventive and therapeutic aid to inflammation periodontal disease.

Menta spp. is considered an anti-infective and aroma.

While many of the components of the mixture therapeutic benefits arewell known the following are benefits are highlighted. Neem (Azadirachtaindica), is a member of the Meliaceae family, has therapeuticsimplication in the diseases prevention and treatment. It is consideredthat Azadirachta indica shows therapeutic role due to the rich source ofantioxidant and other valuable active compounds such as azadirachtin,nimbolinin, nimbin, nimbidin, nimbidol, salannin, and quercetin.

Punica granatum is known for having high antioxidant activity and Mentaspp. is considered an anti-infective and aroma as well as antispasmodicand anti-inflammatory effects.

A potential source of effective chlorotoxin's is the venom fromScorpions that are part of the order Scorpiones and the class Arachnida.They are invertebrates that possess eight legs and a two-segmented bodycomposed of a cephalothorax and abdomen. This is the classification ofscorpions: Kingdom Animalia (Animals); Phylum: Arthropoda (Arthropods);Subphylum: Chelicerata; Class: Arachnida (Arachnids); and Order:Scorpiones (Scorpions). Current records show that there are 1,004 knownspecies. The number of species and the potential of compounds from themore than 1000 known species combined with the knowledge base of bothnative American, Indian homeopathic medicine and other homeopathicliterature indicate that there is a wealth of opportunity in thechlorotoxin's of scorpion species to elevate the symptoms of effectivetreatments to disease states such as heart disease, cancer, Alzheimer's,epilepsy, inflammation and pain management.

Research to date shows that natural based formulations especiallycomprised of natural materials such as CDB and clove oil and naturalchlorotoxins can be used for targeting cancer, heart disease,Alzheimer's, epilepsy, inflammation and pain management.

Hence, there is need for a formulation for treating exposed dentin whichis the result of loss of protective enamel comprised of promisingnatural based formulations, especially CBD and clove oil and naturalchlorotoxins, for targeting inflammation and pain and with less or noside effects. Also, there is a need for a method for synthesizing theformulation comprising clove oil and CBD and natural chlorotoxins forminimizing inflammation and pain in dental work.

There is also a need to improve the reduce the bond time and increasethe bond between the bioglass and the treated dentin.

Accordingly, the present disclosure provides methods repairing teeththat have been affected by the loss of enamel. In certain embodiments,such methods include, first, applying a diluted hydrogen peroxidemixture to the teeth, and then, applying an etching compositioncomprising an etchant to a tooth to etched the exposed dentin surfacethat has been exposed by the loss of enamel; applying a non-aqueoussolvent composition to the etched dentin surface; the non-aqueoussolvent composition includes a bioactive glass substantially lackingsilanol groups, and a non-aqueous solvent to the primed exposed dentinsurface, and where the non-aqueous solvent composition provide forformation of a hybrid layer, where the hybrid layer comprises dentin andthe bioglass composition. However, the process and the effect of loss ofenamel has many negative repercussions for the patient. The instantinvention over comes the issues of inflammation, infection, pain andbone resorption from bone loss which are associated with the loss ofdentin.

To reduce the time, reduce the bond time and increase the bond betweenthe bioglass and the treated dentin the instant invention providesmethods that utilizes electromagnetic field.

The acid etch step in the tooth restoration process exposes the dentintubules. The diameter of the open tubules measures about 1 μm. To allowpenetration into the tubules, the bioglass has been manufactured to aparticle size of less than 1 μm maximum. By adding a combination ofclove oil, Cannabidiol (CBD) oil, Boswellia and chlorotoxin and otherinflammation and pain agents the instant invention minimizes pain anddiscomfort associated with the exposed dentin and with the process ofrepair and dental bonding the dentin. The particle size of less than 1μm of the bioglass particles are found to penetrate deeper into thetubules creating a reflective surface that will appear white whenexposed to normal lighting conditions. The penetration of the glassparticles also carries the anti-inflammatory and pain relieve agentsinto the tubules and reduce the inflammation and pain associated withthe condition and the procedure. In addition to occluding the dentintubule with a micro-mechanical bond, it is long known that the bioglasscan, in the aqueous presence of calcium and phosphate, form apatite andwhen the bioglass is subjected to the proper electromagnetic field thebond time is reduced and the bond between the bioglass and the treateddentin is increase. Specifically, the electromagnetic stimulatorincrease the bond strength, bioactivity and promotes the formation ofcarbonated hydroxyapatite MCA).

In exemplary embodiments, the bioactive glass has the followingapproximate composition by weight percentage: 49.5% of the total weightof bioactive glass comprising of SiO₂ 17% of the total weight ofbioactive glass comprising of Na₂O, 26.9% of the total weight ofbioactive glass comprising of CaO, 6.6% of the total weight of bioactiveglass comprising of P₂O₅. In further embodiments, the bioactive glasshas an average particle size of 1 μm or less. In still furtherembodiments, the dental bonding slurry has about 0.5% to about 40% byweight of said bioactive glass. In an exemplary embodiment, the alcoholsolvent is ethanol. The anti-inflammatory and pain reliever componentscontribute between 0.01 to 5% of the total weight of the preparation.

Also provided are kits containing the dental bonding slurry for use inthe subject methods. In certain embodiments, the kits may include adental bonding slurry or gel format that comprises a bioactive glasssubstantially lacking silanol groups and a non-aqueous solventcomprising an alcohol, anti-inflammatory and pain reliever and,optionally, an etching composition. In further embodiments, the kit mayinclude the dental bonding slurry provided as separate components, wherea first component comprises the bioactive glass in the non-aqueoussolvent, where the first component is provided in a container. Infurther embodiments, the kit may include the dental bonding slurryprovided as separate components, where a first component comprises thebioactive glass and the second container the non-aqueous solvent havinganti-inflammatory and pain reliever dissolved in the non-aqueoussolvent.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 shows an electromagnetic field stimulator to reduce the bond timeand increase the bond between the bioglass and the treated dentin.

FIG. 2 shows a kit of the invention.

FIG. 3 shows scanning electron microscopy (SEM) micrographs untreateddentin.

FIG. 4 shows SEM micrographs dentin treated with bioglass.

FIG. 5 shows scanning electron microscopy (SEM) micrographs untreateddentin.

FIG. 6 shows SEM micrographs dentin treated with bioglass.

DEFINITIONS

The term “dentin” as used herein refers to a calcified tissue of thebody that is one of the major components of teeth. Dentin is usuallycovered by enamel that forms the outer surface of the tooth. Dentin is aporous matrix composed of up to 70% hydroxyapatite. Dentin hasmicroscopic channels called dentinal tubules that span the thickness ofthe dentin. Dentinal tubules taper in diameter from the inner to theoutermost surface of the dentin, having a diameter of about 2.5 μm nearthe inner surface of the dentin, about 1.2 μm in the middle of thedentin, and about 900 nm near the outer surface of the dentin. Inaddition, dentinal tubules are surrounded by collagen fibers that forman extensive collagen network.

The term “prime” or “priming” as used herein means applying a compoundto an acid-etched surface of a tooth to facilitate stabilization of thecollagen network in the demineralized dentin, such as may result from anetching process. Dental primers also include self-etching primers, whichachieve the steps of etching and priming in a single application step.Self-etching primers may include acidic monomers. Thus, reference to an“etched and primed surface” is meant to encompass etching and priming inseparate steps or in a single step.

The terms “dental resin adhesive”, “dental adhesive”, “adhesive”,“adhesive resin”, or “resin-based adhesive” as used herein refer tocompounds useful in facilitating a bond between a dental resin compositeto a tooth. Adhesives may include a mixture of monomeric molecules thatpolymerize upon curing. Adhesives may be cured using light or acatalyst. Dental adhesives also include self-etching adhesives. Aself-etching adhesive is an adhesive that contains compounds (i.e., aself-etching primer, such as an acidic monomer, and an adhesive) thatachieve the steps of etching, priming, and bonding in a singleapplication step.

The term adhesives can be “unfilled”, wherein the adhesive is composedof compounds that actively participate in the polymerization and bondingprocess. Adhesives can be “filled”, wherein the adhesive containscompounds that do not participate in the polymerization and bondingprocess. Examples of fillers include, but are not limited to, silicapowder, glass beads, aluminum oxide powder, iron oxide and quartzpowder.

The term “etch” or “etching” as used herein means either applying anacid to the surface of a tooth to partially dissolve the apatite orutilizing a bristle brush to produce irregularities in the surface ofdentin.

The terms bioglass and bioactive glasses are used interchangeably andmay contain but are not limited to silicon, dioxide), sodium oxide,calcium oxide, magnesium oxide, phosphorous pentoxide, and calciumfluoride. Other components may be added such as boron, magnesium,aluminum, iron, titanium, fluorine, and silver. The addition of fluorineto bioactive glass can be rationalized for the following reasons:firstly, that the rate of apatite formation at the glass surface can beenhanced; and secondly, that the apatite formed will be less vulnerableto acid attack, both of which are desirable in bioactive glass to beutilized in dental applications. Magnesium may also be added tobioactive glass, as it has been shown to slow down the rate of apatiteprecipitation, thus leading to more controlled mineralization.

The term “hybrid layer” where the hybrid layer comprises dentin and thebioglass composition.

The term “chlorotoxins” as used herein means a wino acid basic peptidefrom the venom of the scorpion.

The term slurry and Gel are used interchangeably.

The term scorpion refer to arthropods that are members of Arachnidaclass and order Scorpiones based compounds. For this example, the BlueScorpion Venom Chlorotoxin venom is extracted by a mildelectro-stimulation method, that, includes stimulating and scorpionrestraining devices. However, researchers have had success milkingscorpions in the Buthidae family, the Scorpionidae family which includesthe emperor scorpion (Pandinus imperator), and the Heterometrusswammerdami scorpion as well as specific species such as AfricanAndroctonus australis, Hadrurus hirsutus, Albino Scorpions, BlackScorpions or Asian Forest Scorpions, Blue Scorpions, Emperor Scorpions,Deathstalker Scorpions, Lesser Brown Scorpions, Red Claw Scorpions, RedScorpions, Sand Scorpions, Tailless Whip Scorpions and Whip Scorpions.

The terms “substantially asks” or “substantially lacking” as used hereinrefer to a compound that is at least about 60% free, or about 75% free,or about 90-95% free from a component. For example, “substantiallylacking, silanol groups” refers to a compound that is at least about 60%free, or about 75% free, or about 90-95% free of silanol groups.

The term “non-aqueous solvent” is meant to encompass solvents that donot contain water as a predominant component, and includes solvents thatcontain, for example, less than 15% water by volume, less than 10% waterby volume, less than 5% water by volume, less than 1% water by volume,and may contain no detectable water.

The terms anti-inflammatory and pain reliever include compositions cloveoil, Cannabidiol (CBD) oil, Boswellia and chlorotoxin and otherinflammation and pain agents such as Aspirin, or acetylsalicylic acid(ASA).

The term NSAIDs means Nonsteroidal anti-inflammatory drugs (NSAIDs)which block the enzyme cyclooxygenase known as COX enzymes and reduceprostaglandins throughout the body. As a consequence, ongoinginflammation, pain, and fever are reduced. They include aspirin,celecoxib, diclofenac, diflunisal, etodolac, ibuprofen, indomethacin,ketoprofen, ketorolac, nabumetone, naproxen, oxaprozin and piroxicam.

DETAILED DESCRIPTION OF THE INVENTION

Exemplary embodiments of the methods and compositions of the presentdisclosure are provided below. These include methods of utilizingnatural products to reduce the inflammation and pain of gums andgumline, nerves and methods for preparing dentin for bonding to a dentalresin composite, methods for forming an adhesive bond between a dentalresin composite and dentin, methods for making an adhesive compositionuseful in such methods, and methods to reduce the bond time and increasethe bond between the bioglass and dentin, and kits useful in suchmethods.

Before the present invention is described in greater detail, it is to beunderstood that this invention is not limited to embodiments described,as such may, of course, vary. It is also to be understood that theterminology used herein is for the purpose of describing embodimentsonly, and is not intended to be limiting, since the scope of the presentinvention will be limited only by the appended claims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range is encompassed within the invention.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present invention, the preferredmethods and materials are now described.

All publications and patents cited in this specification are hereinincorporated by reference as if each individual publication or patentwere specifically and individually indicated to be incorporated byreference and are incorporated herein by reference to disclose anddescribe the methods and/or materials in connection with which thepublications are cited. The citation of any publication is for itsdisclosure prior to the filing date and should not be construed as anadmission that the present invention is not entitled to antedate suchpublication by virtue of prior invention, Further, the dates ofpublication provided may be different from the actual publication datesthat may need to be independently confirmed.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext dearly dictates otherwise. It is further noted that the claimsmay be drafted to exclude any element, including optional elements. Assuch, this statement is intended to serve as antecedent basis for use ofsuch exclusive terminology as “solely”, “only”, and the like inconnection with the recitation of claim elements, or use of a “negative”limitation.

U.S. Patent application 200919722 discloses a method of using bioglassto treat detin prior to enamel restoration. The disclosure U.S. Patentapplication 2009197221 is hereby incorporated by reference in itsentirety. However, the process disclosed does not provide ananti-inflammatory agent or chlorotoxin component to the mixture that iscapable of reducing pain, inflammation and infection.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features that may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentinvention. Any recited method can be carried out in the order of eventsrecited or in any other order that is logically possible.

The compositions for desensitizing agent for dentin surface of thepresent disclosure will be described first, followed by a detaileddescription of exemplary uses for the compositions for desensitizingagent for dentin surface.

Compositions for Desensitizing Agent for Dentin Surfaces

A composition for preparing dentin for bonding to a dental resincomposite is provided. The term “dental bonding slurry” is intended torefer to any mixture of anti-inflammatory and pain relieversincorporated into a bioactive glass-containing composition that can finda use in one or more steps as a dentin tubule agent according to thepresent disclosure. As noted earlier, enamel erosion occurs when enamelwears down, it can cause tooth decay, exposing dentin and sensitivenerves within the pulp of the teeth, and causes the dentin to be exposedwhich results in significant inflammation and pain associated with thecondition.

Thus, dental bonding slurry compositions include, but are notnecessarily limited to, compositions comprising a suitableanti-inflammatory and pain reliever incorporated into a non-aqueoussolvent (e.g., an alcohol such as ethanol) and bioactive glass (e.g., tobe applied to an etched dentin surface) mixture used to repair thedentin. The bioactive glass present in the dental bonding slurry isgenerally a bioactive glass that substantially lacks silanol groups. Theanti-inflammatory and pain relievers incorporated into the dentalbonding slurry include mixtures and combinations of clove oil,Cannabidiol (CBD) oil, Boswellia and chlorotoxin and other inflammationand pain agents such as Aspirin, or acetylsalicylic acid (ASA). Theinstant invention minimizes pain and discomfort associated with theexposed dentin and with the process of repair and dental bonding thedentin. Exemplary dental bonding slurry's are described in more detailbelow.

The medical literature in India and the traditional system of medicinesand classical records provide details of the pain management techniquesthat utilize small amounts of scorpion venom and the natural productsincluding Cannabidiol (CBD) oil, Boswellia. In nature, scorpionchlorotoxins immobilize the envenomated prey. Research has shown thatchlorotoxins bind preferentially and are capable of relieving pain. Thepresent disclosure provides various embodiments of the presentinvention. The embodiments provide a formulation/composition comprisingphytonutrients and natural chlorotoxins for targeting pain andinflammation without any side effects. The embodiments of the presentinvention also provide a method for the synthesis of a formulationcomprising phytonutrients including cannabis sativa (cannabinoids) andnatural chlorotoxins for targeting inflammation, pain, and infections.(as discussed in Mediators of Inflammation Volume 2010 (2010), ArticleID 903295, http://dx.doi.org/10.1155/2010/903295, Scorpion Venom and theInflammatory Response by Vera L. Petricevich)

In certain cases, the dental bonding slurry can include natural productssuch as clove oil, Cannabidiol (CBD) oil, Boswellia and chlorotoxin andother inflammation and pain agents such as Aspirin, or acetylsalicylicacid (ASA) or other NSAID pain relive medication. The Cannabidiol (CBD),Boswellia and chlorotoxin which are known anti-inflammatory and painreliever agents when suspended in a mixture containing a bioactive glasssubstantially lacking silanol groups and a non-aqueous solventcomprising an alcohol creates a minimal pain material composition usefulin treating dentin restoration and dental bonding. When incorporatedinto a bioactive glass and a suitable non-aqueous solvent then themixture is useful in treating dentin restoration and dental bonding. Insome cases, the dental bonding slurry can comprise from about 0.5% toabout 40% by weight of the bioactive glass. In cases where a higherweight % of the bioactive glass is described, suspension of thebioactive glass in a suitable non-aqueous solvent may be facilitated byuse of a bioactive glass powder having a smaller average particle size(e.g., less than 1 μm average particle size, preferably 0.5 μm) or less.The anti-inflammatory and pain reliever components contribute between0.01 to 5% of the total weight of the preparation. The kit can alsoinclude an electromagnetic stimulator which provides electromagneticexposure as treatment procedure to increase the bond strength of thebioactive glass by promoting bioactivity and the formation of carbonatedhydroxyapatite (HCA).

In one embodiment, the dental bonding slurry can include naturalproducts such as clove oil, Cannabidiol (CBD) oil, Boswellia andchlorotoxin and other inflammation and pain agents such as aspirin, oracetylsalicylic acid (ASA) or other NSAID pain relive medication. TheCannabidiol (CBD), Boswellia and chlorotoxin which are knownanti-inflammatory and pain reliever agents when suspended in a mixturecontaining and a bioactive glass suspended in a suitable non-aqueoussolvent (e.g., a slurry). In these embodiments, the dental bondingslurry comprises about 5% by weight, about 10% by weight, about 15% byweight, about 20% by weight, about 25% by weight, about 30% by weight,about 35% by weight, or about 40% by weight, or more, of the bioactiveglass. The anti-inflammatory and pain reliever components contributebetween 0.01 to 5% of the total weight of the preparation. Theanti-inflammatory agents can be selected from clove oil, Cannabidiol(CBD) oil, Boswellia and chlorotoxin and other inflammation and painagents such as aspirin, or acetylsalicylic acid (ASA) or other NSAIDpain relive medication. The amount of bioactive glass incorporated intothe dental bonding slurry can vary with the average particle size of thebioactive glass. Smaller average particle sizes (e.g., 1 μm or less) mayallow for more bioactive glass to be suspended in the dental bondingslurry mixture.

In certain, cases, the dental bonding slurry can include naturalproducts such as clove oil, Cannabidiol (CBD) oil, Boswellia andchlorotoxin and other inflammation and pain agents such as aspirin, oracetylsalicylic acid (ASA) or other NSAID pain relive medication. TheCannabidiol (CBD), Boswellia and chlorotoxin which are knownanti-inflammatory and pain reliever agents when suspended in a mixturecontaining and a bioactive glass used in the dental bonding slurry isBioglass 45S5 and has the following approximate composition by weightpercentage: 49.5% of the total weight percent is SiO₂, 17% of the totalweight percent is Na₂O, 26.9% of the total weight percent is CaO, 6.6%of the total weight percent is P₂O₅. In other cases, the bioactive glassused in the dental bonding slurry is Bioglass F glass and has thefollowing approximate composition by weight percentage: 44% of the totalweight percent is SiO₂, 23% of the total weight percent is Na₂O, 10% ofthe total weight percent is CaO, 4.5% of the total weight percent isMgO, 6% of the total weight percent is P₂O₅, 12.5% of the total weightpercent is CaF₂. The anti-inflammatory and pain reliever componentscontribute between 0.01 to 5% of the total weight of the preparation. Ineither case, the bioactive glass used in the dental bonding slurry mayhave an average particle size of 1 μm or less and preferably 0.5 μm.Bioglass 45S5 or Bioglass F powders may be prepared by methods known tothose of skill in the art, including but not limited of sinteringprocess to achieve maximum compressive strength and high energy ballmilling of bioglass.

The bioactive glass is dispersed in the dental bonding slurry via asolvent. The solvent is preloaded with the anti-inflammatory mixturesuch that the dental bonding slurry can include natural products such asclove oil, Cannabidiol (CBD) oil, Boswellia and chlorotoxin and otherinflammation and pain agents such as aspirin, or acetylsalicylic acid(ASA) or other NSAID pain relive medication. The anti-inflammatory andpain reliever components contribute between 0.01 to 5% of the totalweight of the preparation. The Cannabidiol (CBD), Boswellia andchlorotoxin which are known anti-inflammatory and pain reliever agentswhen suspended in a mixture containing and a bioactive glass. Asdiscussed below, the water content of the solvent is selected so thatreaction of the bioactive glass with water in the solvent isinsignificant, and may be so low as to avoid such reaction.

The key to the dental bonding slurry performance anti-inflammatory andpalm oil that allow penetration into the tubule. By adding a combinationof clove oil, Cannabidiol (CBD) oil, Boswellia and chlorotoxin and otherinflammation and pain agents the instant invention minimizes pain anddiscomfort associated with the exposed dentin and with the process ofrepair and dental bonding the dentin. The bioglass is then added to themixture and the small particle size distribution, 1 μm maximum of thebioglass component are designed to allow them to fill the dentinaltubules. The acid etch step in the tooth restoration process exposes thedentinal tubules. The diameter of the open tubules measures about 1 μm,therefore, the bioglass must have a maximum dimension of less than 1 μm,preferably 0.5 μm. To allow penetration into the dentinal tubules,bioglass needs to be manufactured to a particle size of less than 1 μmand preferably 0.5 μm. At this size, the particles are found topenetrate deeper into the tubules and will result in improved sealing.In addition to occluding the dentinal tubule with a micro-mechanicalbond, it is long known that the bioglass can, in the aqueous presence ofcalcium and phosphate, form apatite to further prevent sensitivity, lockout micro-leakage through the tubules, and increase the appearance of awhiter color enamel structure. However, the time to achieve bondstrength and the bond the bonding time needs to be reduced.

The dental bonding slurry theoretically has the added benefit offacilitating the inhibition of leakage of particulate materials and/orfluid from the dentin or oral environment treated with the dentalbonding slurry. Inhibition of leakage can include both microleakage andnanoleakage. Microleakage is the seepage of fluids, debris, and/ormicroorganisms (e.g., bacteria) into micrometer-sized gaps(approximately 10⁻⁶ m) between any dental restoration and a tooth.Nanoleakage is the seepage of fluids, debris, and/or microorganisms(e.g. bacteria) into nanometer-sized gaps (i.e., approximately 10⁻⁹ m)between any dental restoration and a tooth. Without being held totheory, the ability of bioactive glasses to promote the formation ofapatite in aqueous environments that contain calcium and phosphate(e.g., saliva) can facilitate inhibition of leakage at the bondedinterface through a mechanism of self-sealing due to the formation ofapatite. This sealing prevents the intrusion of materials that wouldfurther discolor the tooth. The instant invention has shown thatapplying electromagnetism immediately after the application of thedental bonding slurry in proves the bond strength and reduces thebonding time required. This means that the enamel restoration processcan be performed on the patient sooner than previous treatment methods.

The example utilizes the Blue Scorpion Venom Chlorotoxin venom howeverthe opportunity to expand the viable chlorotoxin pool of compounds byutilizing any one of the more than 1004 known species of scorpion's inthe treatment of disease's such as heart disease, cancer, Alzheimer's,epilepsy, inflammation and pain management is incorporate because anyone of the vast number of scorpion's could be used as a donor animal andthis specification includes the incorporation of any of these animalsbeing used as an alternative sources of chlorotoxin's. For this example,the Blue Scorpion Venom Chlorotoxin venom is extracted by a mildelectro-stimulation method, that includes stimulating and scorpionrestraining devices. However, researchers have had success milkingscorpions in the Buthidae family, the Scorpionidae family which includesthe emperor scorpion (Pandinus imperator), and the Heterometrusswammerdami scorpion as well as specific species such as AfricanAndroctonus australis, Hadrurus hirsutus, Albino Scorpions, BlackScorpions or Asian Forest Scorpions, Blue Scorpions, Emperor Scorpions,Deathstalker Scorpions, Lesser Brown Scorpions, Red Claw Scorpions, RedScorpions, Sand Scorpions, Tailless Whip Scorpions and Whip Scorpions.

Once the venom is extracted, it is frozen and then lyophilized into apowder form that can be added to the ethanol slurry in the ratio 1-partvenom 10,000 parts by weight of ethanol, then mixing thoroughly. The1-part venom to 10,000 parts ethanol is preferred. However, clinicallyeffective slurries with ratios from 1 to 1000 parts venom and 1000 to20000 parts by weight ethanol have been made successfully.

Bioactive Glass Compounds

Bioactive glasses elicit a series of chemical reactions when they arebrought into contact with an aqueous environment that contains calciumand phosphate, such as bone or tissue, leading to the formation ofcarbonated hydroxyapatite (HCA), similar to the mineral that formsteeth. The formation of HCA creates a bond between the bioactive glassand the dentin. The bond may be a mechanical bond and/or due to achemical interaction between the bioactive glass and the dentin, formingHCA bonds to specific amino acids within the collagen matrix of thedentin.

Bioactive glasses may contain, but are not limited to, silicon dioxide(SiO₂), sodium oxide (Na₂O), calcium oxide (CaO), magnesium oxide (MgO),phosphorous pentoxide (P₂O₅), and calcium fluoride (CaF₂). Othercomponents may be added, such as boron, magnesium, aluminum, iron,titanium, fluorine, and silver. The addition of fluorine to bioactiveglass can be rationalized for the following reasons: firstly, that therate of apatite formation at the glass surface can be enhanced; andsecondly, that the apatite formed will be less vulnerable to acidattack; both are desirable in bioactive glass to be utilized in dentalapplications. Magnesium may also be added to bioactive glass, as it hasbeen shown to slow down the rate of apatite precipitation, thus leadingto more controlled mineralization.

Bioactive glass for use in the compositions and methods disclosed hereingenerally are characterized by having predominantly more silicon dioxide(SiO₂) groups than silanol (H₃SiOH) groups. This improves the dentalbonding. In general, this can be achieved by avoiding bioactive glasscontact with water and/or hydrogen atoms, thereby inhibiting productionof silanol in the bioactive glass composition (e.g., as by the reactionSi—O—Na⁺H⁺+OH⁻→Si—OH⁺+Na⁺+OH⁻). Accordingly, bioactive glass can bedescribed as having as a total of SiO₂ and H₃SiOH groups, greater than50% SiO₂ groups, greater than 60% SiO2 groups, greater than 75% SiO₂groups, greater than 85% SiO₂ groups, greater than 90% SiO₂ groups,greater than 95% SiO₂ groups, and can be described as having, as a totalof SiO₂ and H₃SiOH groups, at least 55% SiO₂ groups, at least 65% SiO₂groups, at least 80% SiO₂ groups, at least 90% SiO₂ groups or more. Insome embodiments, the bioactive glass is characterized as “substantiallylacking silanol groups,” as outlined above, refers, to a bioactive glassthat is at least about 60% free, or about 75% free, or about 90-95% freeof silanol groups.

Bioactive glass compositions can be maintained in a relative“dehydrated” state prior to use. The term “dry” as used herein can referto compositions kept at ambient conditions, for example, at standardtemperature, pressure, and humidity. It should be noted, however, that a“dry” compound can be provided in a substantially non-aqueous solvent(e.g., an alcohol). Thus, for example, slurries of bioactive glasspowder in suitable non-aqueous solvent (e.g., an alcohol (e.g. ethanol))are encompassed within the meaning of a “dry” bioactive glasscomposition. In some cases, the bioactive glass compositions may bestored in suitable packaging to keep the bioactive glass compositionsdry (e.g. a sealed container).

Bioactive glass for use in the compositions and methods disclosed hereincan be selected to have an average particle size that allows thebioactive glass particles to penetrate into the lumens of dentinaltubules. Dentinal tubules generally have diameters of approximately 0.8μm to 1 μm before etching, and may have diameters of approximately 1 μmor greater after etching. Accordingly, suitable bioactive glasscompositions for incorporation in the dental bonding slurry of thepresent disclosure include those having an average particle size of 1 μmor less, preferably 0.5 μm. Bioactive glass compositions can have aparticle size distribution of at least 25%, at least 50%, at least 75%,at least 85%, or more (e.g., 99%) of the particles are of an averageparticle size of 1 μm or less.

Exemplary Bioactive Glasses are Described Below. Bioglass 45S5 andBioglass F (F Glass)

The invention can utilize two different bioglass compositions BioglassF″, or “F Glass”, or Bioglass ® (45S5) in the slurry.

Bioglass formulation 45S5, or bioglass 45S5, is a bioactive glass thatis composed of 49.5% SiO₂, 17.0% NaO, 26.9% CaO, and 6.6% P2O₅, allvalues are in weight %. Therefore, for example 6.6% of the total sampleweight of Bioglass 45S5 would be P₂O₅.

Bioglass F formulation is composed of SiO2 (44%), Na2O (23%), CaO (10%),MgO (4.5%), P2O5 (6%), CaF2 (12.5%) all values are in weight %.Therefore, for example 12.5% of the total sample weight of Bioglass Fwould be CaF2.

In certain embodiments, bioglass 45S5 and Bioglass F is in a powderform, and can be provided as a dry powder. In these embodiments, theboth bioglass powder is composed of nanoparticles with an averageparticle size of <1 μm or less and the preferred size is 0.5 μm or less.An average particle size of 1 μm or less allows the bioactive glasspowder to penetrate into the lumens of dentinal tubules that havediameters of approximately 0.8 μm to 1 μm before etching and may havediameters of approximately 1 μm or more after etching. In addition, anaverage particle size of 1 μm or less can facilitate penetration of thebioactive glass into the partially etched intertubular dentin that hasopenings of less than 1 μm. Bioglass 45S5 powder may be prepared bymethods known to those of skill in the art, including, but not limitedto, planetary ball milling of bioglass 45S5 glass chips or utilizationof planetary lapping equipment to grind the glass into fine particles.

F Glass

BioGlass F or F Glass is a bioactive glass that has the followingapproximate composition by weight percentage: SiO₂ (44%), Na₂O (23%),CaO (10%), MgO (4.5%), P₂O5 (6%), and CaF₂ (12.5%). In certainembodiments, F glass is a powder, and can be provided as a dry powder.In these embodiments, the F glass powder may be composed ofnanoparticles with an average particle size of less than 1 μm andpreferable 0.5 μm of less. An average particle size of 1 μm or lessallows the bioactive glass powder to penetrate the lumens of dentinaltubules, that have diameters of approximately 0.8 to 1 μm before etchingand may have diameters of approximately 1 μm or more after etching orcleaned. In addition, an average particle size of 1 μm or less may allowthe bioactive glass to penetrate the partially etched or cleanedintertubular dentin that has openings of less than 1 μm. F glass powdermay be prepared by methods known to those of skill in the art,including, but not limited to, planetary ball milling of chips of Fglass.

Bioglass 45S5 or Bioglass F powders may be prepared by methods known tothose of skill in the art, including but not limited to planetary ballmilling of Bioglass 45S5 glass chips or utilization of lappingtechnology.

Solvents

The solvent used to disperse the bioactive glass in the dental bondingslurry can be any suitable solvent available in the art. As describedabove, bioactive glasses elicit a series of chemical reactions when theyare brought into contact with tissue or any aqueous environment thatcontains calcium and phosphate, leading to the formation of carbonatedhydroxyapatite (HCA). Accordingly, the solvent can be described as a“non-aqueous solvent” referring to solvents that do not contain water asa predominant component, and include, for example, solvents that containless than 10% water by volume, less than 5% water by volume, less than1% water by volume, and may contain no detectable water. Suchnon-aqueous solvents, thus, have a water content that is sufficientlylow to avoid reaction of the bioactive, glass so as to significantlygenerate silanol groups. Thus, in some cases, the solvent for theadhesive composition contains less than 5% to less than 1% water, andcan substantially lack water. In certain embodiments, the solvent is analcohol. In these embodiments, the alcohol solvent may be ethanol,isopropyl alcohol, or any other suitable alcohol. In other cases,suitable solvents may include acetone. In some cases, the non-aqueoussolvent is other than acetone.

The amount of solvent used in the dental bonding slurry can varyaccording to the desired properties of the composition. For example,solvent can be added or removed (e.g., by vacuum or evaporation), so asto provide a final dental bonding slurry having a desired viscosity orconsistency. For example, the composition can be flowable at ambienttemperature, and may be of a consistency compatible with painting thecomposition onto the surface to be treated. Exemplary compositions canhave the consistency of a fluid paste or gel. In general, the viscosityof the composition is compatible with its use so as to allow thecomposition to penetrate to a sufficient degree into the dentin matrix.

Bioactive Glass-Containing Dental Bonding Slurry or Use in Preparationand Dentin Repair Methods

As noted above, dental bonding slurry or gel containing bioactive glasscan include compounds to facilitate one or more steps of a dentalbonding method according to the present disclosure. Thus, dental bondingslurry or gel can provide for activity as one or more of an etchant (asin, etching of dentin), a suitable non-aqueous solvent, bioglass, orcombinations thereof (e.g., to provide for any combination (includingall) steps of dental bonding methods). In these embodiments, the dentaletchant may be an inorganic or organic acid, such as but not limited tophosphoric acid, maleic acid, or citric acid. However, the dentin canalso be prepared by vigorous brushing with a suitable nylon brush toproduce irregularities in the surface of dentin.

For example, in one embodiment, the dental bonding slurry can include aprimer, a bioactive glass, chlorotoxin a powder form that can be addedto the ethanol to form a slurry. A slurry of 20% or 40% (w/v) bioactiveglass of the formulation 45S5 (Bioglass 45S5, SEM-COM, Toledo, Ohio) inethanol mixture is preferred. The bioglass is initially prepared. Theaverage particle size of the ground bioactive glass powder is less than1 μm, and it was prepared by planetary ball milling of glass chips.

The ethanol mixture is prepared with ethanol with comprised of ethanol,0.01% dove oil, 0.03% Cannabidiol (CBD) oil, 0.02% Boswellia and 0.001%chlorotoxin from a Blue Scorpion Venom Chlorotoxin. If aspirin (ASA) orother NSAID is to be used as the anti-inflammatory agent, theaspirin/NSAID would be loaded into the ethanol by weight equal to 0.05%aspirin. The scorpion venom chlorotoxin is added to the slurry 1-partvenom 10,000 parts by weight of ethanol mixture, then the mixture isthoroughly mixed to insure that all the ingredients are distributedwithin the mixture. The slurry is created by adding the Bioglass to theethanol mixture such that it comprises of 20% of the slurry by weigh or40% by volume. The slurry is then formed by mixing all the ingredientsthoroughly to insure that all the ingredients are distributed within theslurry.

The normal method of preparing the tooth is to prepared the tooth byusing an etchant and exposing the dentin, then the process is to applythe slurry/gel so that it penetrates the dentinal tubules. The glassseal to the tubules to prevent microleakage and sensitivity. The nextstep is to rebuild the enamel, which is the outer surface of the toothto protect the dentin and encase the glass. This process does not resultin rapid bonding of the glass to the dentin and can result ininflammation and in some cases an infection. The instant invention useof clove oil, Cannabidiol (CBD) oil, Boswellia, aspirin or an NSAID andchlorotoxin is designed to overcome the problems currently experiencedby patient. Secondly the instant invention uses an electromagnetic fieldto cure and increase the bond strength between the glass and the dentinby promoting the formation of carbonated hydroxyapatite (HCA).

If the application requires the use of a gel then conventional gelformulations can be used such as a gel based on Carbomer 934, Sodiumcarboxymethylcellulose (SCMC) or a hydroxypropyl methylcellulose (HPMC).

Composition of Gel Formulations with Different Polymers (Carbomer 934,SCMC and HPMC K₄M)

TABLE 1 Ingredients (g) Formulation 1 Formuiation 2 Formulation 3Carbomer 934 1 — — Sodium CMC — 3 — HPMC K₄M — — 2 Golnar extract 12 1212 PEG 400 13 13 13 Potassium Sorbate 0.1 0.1 0.1 Purified water to 100100 100

Preparation of SCMC Gel

Using the amounts on Table 1, potassium sorbate was dissolved in 50° C.purified water. Then an exact amount of SCMC was slowly added to itwhile being mixed with magnetic stirrer in 1200 rpm for 30 minutes tillit was completely homogenous. Then the ingredients clove oil,Cannabidiol (CBD) oil, Boswellia, aspirin or an NSAID and chlorotoxin isweighted and added to polyethylene glycol 400 (PEG 400). The extract wasadded slowly to the gel and mixed till uniform.

Preparation of HPMC Gel

Using the amounts on Table 1, potassium sorbate was dissolved in aboutone third of the formulation's water heated to 83° C. and then aspecific amount of HPMC was slowly added and mixed using magneticstirrer in 1200 rpm. The remaining water was cooled and slowly added andmixed till a uniform gel was achieved. The gel remained in refrigeratorovernight (hot/cold technique). Then an exact amount of concentratedpomegranate flower extract was separately added to PEG 400 and mixed andthen gradually added to the gel.

Preparation of Carbomer 934 Gel

Using the amounts on Table 1, first potassium sorbate (as preservative)was dissolved in 40° C. purified water and then a specific amount ofcarbomer 934 was mixed with it till homogenous using a magnetic stirrerwith 1200 rpm for 30 minutes. A determined amount of concentrated punicaextract was weighed and mixed well with PEG 400. This mixture was slowlyadded to the gel and mixed to achieve a uniform gel. While monitoringthe pH, triethanolamine was added to the gel for it to reach a pH ofabout 6.

Resuming the disclosure of the invention with respect to a slurry. Theslurry of the invention is applied to the exposed dentin and vacuumapplied at 530 mm Hg for one minute; the sample surface was kept moistby re-applying the slurry every few seconds. After removal from thevacuum, any excess solid was gently rinsed away with deionized water.

Then an electromagnetic stimulator similar to that disclosed in U.S.Pat. No. 6,592,509 which the disclosure of is incorporated in itsentirety by reference. The electromagnetic stimulator is placed over thepatients head and proximal to the tooth or teeth being treated. Theelectromagnetic stimulator is connected to a direct current powersupply. The electromagnetic stimulator consists of a coil. The voltageof the AC power supply is set to 12 volts AC and current flow throughthe coil is about four amps. The current is left on and theelectromagnetic stimulator is allowed to bath the dental repair area for1 to 10 minutes depending on the amount of curing that is desired. Theelectromagnetic stimulator increase the bond strength, bioactivity andpromotes the formation of carbonated hydroxyapatite (HCA). Applying adevice as described in U.S. Pat. No. 6,592,509 has been shown to improvehealing and bone formation. U.S. Pat. No. 7,361,136 provides additionaldata that electromagnetic stimulation increases or restores the healingprocess. The objective of applying bioglass to the dentin is to increasethe bond strength and promotes the formation of carbonatedhydroxyapatite (HCA) which is affected by the electromagneticstimulation which increases the healing process and the integration ofthe bioglass into the structure of the dentin. Otherwise the repairprocess of applying enamel over the exposed and treated dentin isdepending on the healing to occur after the email is applied. By usingthe electromagnetic stimulator, we promote the integration of thebioglass with the dentin.

Other research has reinforced the use of bioglass materials. Some of themost promising biomaterials for application in bone tissue engineeringare bio ceramics, such as hydroxyapatite (HA), calcium phosphates,bioactive glasses and related composite materials combining bioactiveinorganic materials with biodegradable polymers.

As described in Bioactive Glass and Class-Ceramic Scaffolds for BoneTissue Engineering Lutz-Christian Gerhardt 1 and Aldo R.Boccaccini—Bioactive inorganic materials are capable of reacting withphysiological fluids forming tenacious bonds to bone through theformation of bone-like hydroxyapatite layers leading to effectivebiological interaction and fixation of bone tissue with the materialsurface. Moreover, in the case of silicate bioactive glasses, such as45S5 Bioglass®, reactions on the material surface induce the release andexchange of critical concentrations of soluble Si, Ca, P and Na ions,which can lead to favorable intracellular and extracellular responsespromoting rapid bone formation.

In addition, U.S. Patent application 20040086661 which the disclosure ofis incorporated in its entirety by reference describes the process ofsintering of bioactive glass with localized electromagnetic energy tolimit disruption of organic material.

In these embodiments, the dental bonding slurry finds use in methodsthat include the sequential steps of: etching or cleaning with asuitable nylon bristle brush; and contacting the etched surface ofdentin with the dental bonding slurry, such that the dental bondingslurry is applied to the etched surface of dentin. Thus, for example,the dental bonding slurry includes a bioactive glass and a non-aqueoussolvent. In these embodiments, the dental bonding slurry may find use inmethods that include contacting a tooth with the dental bonding slurry,such that the steps of etching and priming are achieved in a singleapplication. In any of these embodiments, the method may further includecontacting the etched and primed surface of dentin with an adhesive tofacilitate the application of the dental bonding slurry as part of therestoration of teeth. It is imperative that the slurry is thoroughlymixed to insure that all the ingredients are distributed within theslurry.

In other embodiments, the non-aqueous solvent such as ethanol includes;clove oil, Cannabidiol (CBD) oil, Boswellia and chlorotoxin from a BlueScorpion Venom Chlorotoxin, aspirin (ASA) or other NSAID used as theanti-inflammatory agent and a primer, a bioactive glass of 0.1 μm orless and preferable less than 0.5 μm. In these embodiments, the dentalbonding slurry may find use in methods that include contacting a toothwith an etchant to provide an etched dentin surface, and contacting theetched dentin with the dental bonding slurry, such that the steps ofpriming and dental bonding are achieved in a single application step.

In other embodiments, the dental bonding slurry includes a suspension(e.g., slurry) of a bioactive glass in a non-aqueous solvent. In theseembodiments, the dental bonding slurry may find use in methods thatinclude the steps of etching; contacting the etched surface of dentinwith the dental bonding slurry; priming; and dental bonding.

In any of the above embodiments the solvent may be an alcohol, such as,but not limited to, ethanol.

Method of Snaking the Electromagnetic Stimulator

As depicted in FIG. 1 an electromagnetic stimulator device 2022 which ispositionable about the region of dental work to be treated and AC source2023 through which AC current is delivered to the stimulator device2022. In addition, the system 2020 includes means, generally indicated2024, for providing altering the current flow delivered to the device2022 through cable 2021.

The stimulator device 2022 includes an electrically-conductive band 2026which is sized to be positioned about the region of the dental work tobe treated with the system 2020, the positive electrode 2028 from thepower supply is attached to contact 2032 and the negative electrode 2029is connected to contact 2034 wherein each contact 2032 or 2034 isconnected to the coil 2021 and coil 2021 encircles a dental area beingtreated.

During use of the electromagnetic stimulator device 2022, AC current isdelivered from source/generator 2023 through to the coil 2021 which, inturn, generates a corresponding electromagnetic field within theinterior opening of the stimulator device 2022 so that by positioningthe dental area being treated within the interior opening of thestimulator device 2022, the dental area being treated is exposed to thefield established within the band stimulator device 2022. Theelectromagnetic stimulator increase the bond strength and promotes theformation of carbonated hydroxyapatite (HCA).

Methods of Leaking the Slurry

Methods for making a dental bonding slurry for dental bonding, ingeneral, can involve combining a bioactive glass as described above witha suitable non-aqueous solvent such as ethanol, clove oil, Cannabidiol(CBD) oil, Boswellia and chlorotoxin from a Blue Scorpion VenomChlorotoxin, aspirin (ASA) or other NSAID used as the anti-inflammatoryagent and a primer, a bioactive glass of 1 μm or less preferably 0.5 μmor less (e.g., to generate a gel or slurry)

In certain cases, the method includes mixing a bioactive glass, asdescribed above, such that it is combined with a non-aqueous solvent(e.g., acetone or an alcohol, such as, but not limited to, ethanol)clove oil, Cannabidiol (CBD) oil, Boswellia and chlorotoxin from a BlueScorpion Venom Chlorotoxin, aspirin (ASA) or other NSAID used as theanti-inflammatory agent and a primer, prior to combining with thebioactive glass.

The types and amounts of bioactive glass as well as the types of solventcan be those as exemplified herein.

The methods for production of a dental bonding slurry contemplateproduction of intermediate compositions, that can later be combined toform the final dental bonding slurry. For example, the bioactive glasscan be provided in a non-aqueous solvent in a first container. Inanother example, the bioactive glass can be provided as a powder in afirst container and a non-aqueous solvent such as ethanol, clove oil,Cannabidiol (CBD) oil, Boswellia and chlorotoxin from a Blue ScorpionVenom Chlorotoxin, aspirin (ASA) or other NSAID used as theanti-inflammatory agent and a primer, provided in a second container.All or part of the contents of the two containers can then be combinedprior to use, according to directions which can be optionally packagedwith the containers.

Methods of Use

The dental bonding slurry/gels described herein may be used in dentalrestoration procedures to restore a tooth or teeth when there has been asignificant loss of enamel and the dentin is exposed. Generally, thesteps involved for dental bonding a tooth include etching the tooth,applying the priming and bioglass slurry to the tooth, so that it isinfused into the dentinal tubules, applying proper electromagnetic fieldto the bioglass mixture so that the bond time is reduced and the bondbetween the bioglass and the treated dentin is increase. Theelectromagnetic stimulator increase the bond strength and promotes theformation of carbonated hydroxyapatite (HCA).

Effectively dental bonding of the tooth may require preparation of thetooth prior to dental bonding due to the hydrophilic nature of dentaltissue, such as dentin. To facilitate the formation of a mechanical bondbetween the bioglass and dentin, the steps described herein of etching,brushing, priming, and dental bonding may be used.

Etching involves applying an acid to the surface of a tooth tosuperficially demineralize the apatite of dentin or prepared the dentinsurface by vigorous brushing with a suitable nylon bristle brush toproduce irregularities in the surface of dentin matrix.

Etching may also remove surface contaminants, also known as the “smearlayer,” on the surface of dentin, etching or brushing the dentin exposesa layer of collagen fibers. Removal of the smear layer also exposes thedentinal tubules. Etching increases the surface area available fordental bonding and facilitates penetration of the bioglass into theporosities in the dentin matrix revealed by the etching procedure.Penetration of the bioglass into the dentin matrix forms a hybrid layerthat is composed of the dentin and the bioglass. This facilitates theformation of a mechanical bond between the dentin tubulars and thebioglass. Dental etchants may be an inorganic or organic acid such as,but not limited to, phosphoric acid, maleic acid, citric acid. Applyingproper electromagnetic field to the bioglass mixture so that the bondtime is reduced and the bond between the bioglass and the treated dentinis increase. The electromagnetic stimulator increase the bond strengthand promotes the formation of carbonated hydroxyapatite (NCA).

The subsequent step of dental bonding the dental resin composite to thedentin with the dental bonding slurry may include contacting the, etchedsurface of dentin with the dental bonding slurry. Prior to contactingthe etched and/or primed surface of dentin with the dental bondingslurry, the dental bonding slurry may be made as described herein. Insome cases, the dental bonding slurry may be made in advance and storeduntil used. The dental bonding slurry may be stored in a sealedcontainer, such that, during storage, the dental bonding slurry remainssubstantially free of water. However, to achieve a suitable bond in atimely manner an electromagnetic field needs to be applied to thebioglass mixture so that the bond time is reduced and the bond betweenthe bioglass and the treated dentin is increase. The electromagneticstimulator increase the bond strength, bioactivity and promotes theformation of carbonated hydroxyapatite (HCA) on the surface of thetooth.

Application of Bioactive Glass-Containing Suspension

In certain embodiments, the method includes the steps of etching whichinvolves applying an acid to the surface of a tooth to superficiallydemineralize the apatite of dentin or prepared the dentin surface byvigorous brushing with a suitable nylon bristle brush to produceirregularities in the surface of dentin, contacting the surface ofdentin with a slurry of a bioactive glass in a non-aqueous solventcontaining clove oil, Cannabidiol (CBD) oil, Boswellia and chlorotoxinfrom a Blue Scorpion Venom Chlorotoxin, aspirin (ASA) or other NSAIDused as the anti-inflammatory agent and a primer, and dental bonding. Inthese embodiments, the dentin is first brushed with a nylon bristlebrush vigorously brushing the dentin exposes a layer of collagen fibersto remove the smear layer. Removal of the smear layer also exposes thedentinal tubules.

In these embodiments alternatively in place of brushing one could electto us a dental etchant which may be an inorganic or organic acid, suchas, but not limited to, phosphoric acid, maleic acid, or citric acid.Then, the cleaned dentin is contacted with a suspension of a bioactiveglass (e.g., slurry) in a non-aqueous solvent. In some cases, thenon-aqueous solvent may be an alcohol, such as, but not limited to,ethanol and the solvent has been formulated to contain a mixture ofanti-inflammatory, antiinfection and pain relieve agents such as cloveoil, Cannabidiol (CBD) oil, Boswellia and chlorotoxin from a BlueScorpion Venom Chlorotoxin, aspirin (ASA) or other NSAID used as theanti-inflammatory agent may be contacted with a dental primer and curedwith electromagnetic stimulator. The electromagnetic stimulator increasethe bond strength and promotes the formation of carbonatedhydroxyapatite (HCA).

Then, the primed surface of the dentin may be contacted with anadhesive. The adhesive may be cured as described herein. In some cases,the method also includes contacting the adhesive layer with a dentalresin composite such that the dental resin composite is adhered to thedentin.

Kits

Also, of interest are kits for use in practicing certain embodiments ofthe invention. The components of the kits can be adapted for use in anyof the various methods described herein.

In certain embodiments, the kits can include a dental bonding slurry ofthe present disclosure, that may be provided for immediate use, or maybe provided as separate components to be combined to form the dentalbonding slurry. The dental bonding slurry can be provided in a containerthat can be adapted to facilitate application to an etched dentinsurface. For example, the container can be in the form of a needlelesssyringe fitted with a plunger to provide for application of the contentsof the container to an etched dentin surface, More specifically as shownin FIG. 2, A kit 1000 comprising: a dental bonding slurry 100 comprisinga bioactive glass substantially lacking silanol groups; a non-aqueoussolvent 200 comprising an alcohol and clove oil, Cannabidiol (CBD) oil,Boswellia and chlorotoxin from a Blue Scorpion Venom, aspirin (ASA) orother NSAID used as the anti-inflammatory agent; optionally, an etchingcomposition 201 suitable for use with the dental bonding slurry.

For example, where the dental bonding slurry is provided as separatecomponents (e.g., as described above in the context of methods of makingthe dental bonding slurry), the kit can include a first containercontaining a bioactive glass (e.g., powder) and a second container witha non-aqueous solvent including a mixture of clove oil, Cannabidiol(CBD) oil, Boswellia and chlorotoxin and other inflammation and painagents such as Aspirin, or acetylsalicylic acid (ASA) or other NSAIDpain relive medication a needed.

Optionally, the kit can include instructions for combining all or aportion of the first and second containers to provide a dental bondingslurry. Provided in a second container, all or part of the contents ofthe two containers can then be combined prior to use, according todirections that can be optionally provided with the kit. In oneembodiment, where the dental bonding slurry is provided as separatecomponents to be combined prior to use, the two components aremaintained in separate containers that are not in fluid communication,but that are separated by a frangible or removable wall, that can bebroken, or removed, to facilitate mixing of the two components prior touse.

The kits can optionally include additional components. For example, thekits can include one or both of an etchant, clove oil, Cannabidiol (CBD)oil, Boswellia and chlorotoxin from a Blue Scorpion Venom, aspirin (ASA)or other NSAID used as the anti-inflammatory agent and a primercompatible for use with the dental bonding slurry/gel. Such additionalcomponents can be provided in additional containers as may be desired.

Alternatively, the kits can optionally include additional. components.For example, the kits can include one or both of a bioglass, non-aqueoussolvent such as ethanol, etchant, clove oil, Cannabidiol (CBD) oil,Boswellia, aspirin (ASA) used as the anti-inflammatory agent and aprimer compatible for use with the dental bonding slurry.

The components included in the slurry/gel can be selected from bioglass,etchant, non-aqueous solvent such as ethanol, clove oil, Cannabidiol(CBD) oil, Boswellia, chlorotoxin from a Blue Scorpion Venom, aspirin(ASA), other NSAID and a primer compatible for use with the dentalbonding slurry/gel. Such additional components can be provided inadditional containers as may be desired.

In certain embodiments, the kit may include an etchant and a dentalbonding slurry/gel of bioglass containing clove oil, Cannabidiol (CBD)oil, Boswellia and chlorotoxin from a Blue Scorpion Venom, aspirin (ASA)or other NSAID used as the anti-inflammatory agent in a non-aqueoussolvent such as ethanol, where the etchant and the dental bonding slurryare provided in separate containers. In these embodiments the dentalbonding slurry may include a bioactive glass and a solvent.

In other embodiments, the kit may include a dental bonding slurryprovided in a single container. In some cases, the dental bonding slurrymay include a bioactive glass and a solvent.

In certain embodiments, the, kits will further include instructions forpracticing the subject methods or means for obtaining the same (e.g., awebsite URL directing the user to a webpage that provides theinstructions), where these instructions may be printed on a substrate,where substrate may be one or more of a package insert, the packaging,reagent containers, and the like. In the subject kits, the one or morecomponents are present in the same or different containers, as may beconvenient or desirable.

EXAMPLES

The following examples are, put forth, so as to provide those ofordinary skill in the art with a complete disclosure and description ofhow to make and use the present invention, and are not intended to limitthe scope of what the inventors regard as their invention nor are theyintended to represent that the experiments below are all or the onlyexperiments performed. Efforts have been made to ensure accuracy withrespect to numbers used (e.g., amounts, temperature, etc.), but someexperimental errors and deviations should be accounted for. Unlessindicated otherwise, parts are parts by weight, molecular weight isweight average molecular weight, temperature is in degrees Celsius, andpressure is at or near atmospheric.

Example 1

Studies to, test the dental bonding of dentin in the presence ofbioglass 45S5 were performed.

Preparation of Tooth Samples

The occlusal enamel of six human third molars were removed using a beltsander with 240-grit silicon carbide paper, following which the rootswere removed using a slow-speed saw (IsoMet®, Buehler Ltd., Lake Bluff,Ill.) with water coolant to produce tooth discs approximately 5 mmthick. The exposed dentin was polished with 320-grit silicon carbidepaper. The discs were mounted on open-ended tubes with hot glue andattached to a vacuum trap. Scanning, electron micrographs were taken ofthe Sample 1 (shown in FIG. 3) presenting the dentin 10 and the dentinaltubule 20.

The occlusal dentin was cleaned with a nylon bristle brush by scrubbingthe area for 15 seconds and rinsed for a further 15 seconds withdeionized water. A slurry of 20% or 40% (w/v) bioactive glass of theformulation 45S5 (Bioglass 45S5, SEM-COM, Toledo, Ohio) which has thenominal approximate formula of 49.5% SiO₂, 17.0% NaO, 26.9% CaO, and6.6% P₂O₅, all values are in weight %, in ethanol mixture is preparedwith ethanol. The ethanol comprises of 0.01% by weight of clove oil,0.03% by weight of Cannabidiol (CBD) oil, 0.02% by weight of Boswellia,aspirin (ASA) loaded into the ethanol by weight equal to 0.05% aspirin.Then the mixture is thoroughly mixed to insure that all the ingredientsare distributed within the mixture. The slurry is created by adding theBioglass to the ethanol mixture such that it comprises of 20% of theslurry by weigh. The slurry is then formed by mixing all the ingredientsthoroughly to insure that all the ingredients are distributed within theslurry. Then the dentin is primed by scrubbing the exposed dentin with asuitable nylon bristle brush to produce irregularities in the surface ofdentin

The slurry was applied to the top of the sample. The average particlesize of the ground bioactive glass powder was less than 1 μm, and it wasprepared by planetary ball milling of glass chips. The glass slurry wasprepared with ethanol which comprised of ethanol, 0.01% clove oil, 0.03%Cannabidiol (CBD) oil, 0.02% Boswellia. Vacuum was applied at 530 mm Hgfor one minute after application to the dentin; the sample surface waskept moist by re-applying the slurry every few seconds. After removalfrom the vacuum, any excess solid was gently rinsed away with deionizedwater.

Then an electromagnetic stimulator is connected to an alternatingcurrent power supply. The electromagnetic stimulator consists of a coil,The voltage of the AC power supply is set to 12 volts AC and currentflow through the coil is about four amps. The current is applied to theelectromagnetic stimulator for up to 3 minutes to allow theelectromagnetism to stimulate the dental repair area to cure theslurry/gel. The electromagnetic stimulator increase the bond strength,bioactivity and promotes the formation of carbonated hydroxyapatite(HCA).

Results

Following application of he bioglass,

Second scanning electron micrographs of Sample 1 taken are shown in FIG.4 (dentin 30 and dentinal tubule 40) with a bioglass particle 45 in thetubule.

The above experiments showed that the bioactive glass are effectivelyincorporated into the resin-dentin dental bonding process. Onceincorporated into the dentin, the microparticles of bioactive glass sealthe dentin tubules to prevent sensitivity and microleakage, Theelectromagnetic stimulator stimulates the incorporation of the bioglassinto the dentin and promotes the repair of the dentin. Theelectromagnetic stimulator increase the bond strength and promotes theformation of carbonated hydroxyapatite (HCA).

Example 2

Studies to Test the Dental Bonding of Dentin in the Presence of F Glasswere Performed.

Preparation of Tooth Samples

The occlusal enamel of six human third molars were removed using a beltsander with 240-grit silicon carbide paper, following which the rootswere removed using a slow-speed saw (IsoMet, Buehler Ltd., Lake Bluff,Ill.) with water coolant to produce tooth discs approximately 5 mmthick. The exposed dentin was polished with 320-grit silicon carbidepaper. The discs were mounted on open-ended tubes with hot glue, andthen attached to a vacuum trap. Scanning electron micrographs were takenof the Sample 2 (shown in FIG. 5) presenting the dentin 10 and thedentinal tubule 20.

The occlusal dentin of sample 2 was cleaned with a nylon bristle brushby scrubbing the area for 15 seconds and rinsed for a further 15 secondswith deionized water. A slurry of 40% weight of bioactive glass of theformulation Bioglass F or F Glass and has the following approximatecomposition by weight percentage: 44% of the total weight of bioactiveglass comprising of SiO₂, 23% of the total weight of bioactive glasscomprising of Na₂O, 10% of the total weight of bioactive glasscomprising of CaO, 4.5% of the total weight of bioactive glasscomprising of MgO, 6% of the total weight of bioactive glass comprisingof P₂O₅, 12.5% of the total weight of bioactive glass comprising of CaF₂in ethanol with 0.01% by weight of clove oil, 0.03% by weight ofCannabidiol (CBD) oil, 0.02% by weight of Boswellia and 0.001% by weightof chlorotoxin from a Blue Scorpion Venom Chlorotoxin and by weight of0.05% aspirin. The slurry is created by adding the Bioglass to theethanol mixture such that it comprises of 40% of the slurry by volume.The glass and ethanol mixture is mixed thoroughly to create a slurry.The slurry was applied to the top of the sample by brushing. The averageparticle size of the ground bioactive glass powder was approximately 0.5μm, and it was prepared by high energy ball milling of glass chips. Theglass slurry was prepared with ethanol. Vacuum was applied at 530 mm Hgfor one minute after the slurry was applied to the dentin by brushing;the sample surface was kept moist by re-applying the slurry every fewseconds. After removal from the vacuum, any excess solid was gentlyrinsed away with deionized water.

Then an electromagnetic stimulator is connected to an alternatingcurrent power supply. The electromagnetic stimulator consists of a coil.The voltage of the AC power supply is set to 12 volts AC and currentflow through the coil is about four amps. The current is applied to theelectromagnetic stimulator for up to 3 minutes to allow theelectromagnetism to stimulate the dental repair area to cure theslurry/gel. The electromagnetic stimulator increase the bond strength,bioactivity and promotes the formation of carbonated hydroxyapatite(HCA).

Results

Following application of he bioglass,

Second scanning electron micrographs of Sample 2 taken are shown in FIG.6 (dentin 30 and dentinal tubule 40) with a bioglass particle 45 in thetubule.

The above experiments showed that the bioactive glass are effectivelyincorporated into the resin-dentin dental bonding process. Onceincorporated into the dentin, the microparticles of bioactive glass sealthe dentin tubules. The electromagnetic stimulator stimulates theincorporation of the bioglass into the dentin and promotes the repair ofthe dentin and increases the bond strength and promotes the formation ofcarbonated hydroxyapatite (HCA).

Testing of the Slurry for Reduced Pain and Inflammation.

The first slurry is formulated such that 20% by weight of bioactiveglass of the formulation is 45S5 (Bioglass 45S5, SEM-COM, Toledo, Ohio)having a nominal approximate formulation of which has the nominalapproximate formula of 49.5% SiO₂, 17.0% NaO, 26.9% CaO, and 6.6% P₂O₅,all values are in weight %, and the second part being an ethanol mixturethat is prepared of ethanol and the following additional ingredients,0.01% by weight of clove oil, 0.03% by weight of Cannabidiol (CBD) oil,0.02% by weight of Boswellia and 0.001% by weight of chlorotoxin from aBlue Scorpion Venom Chlorotoxin, aspirin (ASA) loaded into the ethanolby weight equal to 0.05% aspirin. Then the mixture is thoroughly mixedto insure that all the ingredients are distributed within the mixture.The slurry is created by adding the Bioglass to the ethanol mixture suchthat it comprises of 20% of the slurry by weigh. The slurry is thenformed by mixing all the ingredients thoroughly to insure that all theingredients are distributed within the slurry.

The second slurry was formulated to create a slurry of 20% weigh ofbioactive glass of the formulation 45S5 (Bioglass 45S5, SEM-COM, Toledo,Ohio) in ethanol. The slurry is created by adding the Bioglass to theethanol such that it comprises of 20% of the slurry by weigh. The slurryis then formed by mixing all the ingredients thoroughly to insure thatall the ingredients are distributed within the slurry.

Then a patient had two teeth with exposed dentin prepared by cleaningwith a nylon bristle brush by scrubbing the area for 15 seconds andrinsed for a further 15 seconds with deionized water. The patient wasasked to rate the pain level of both cleanings and rated the level ofpain on a 1 to 10 scale for both teeth and the patient rated the pain asa 6.

The then first slurry was applied to one of the patients teeth. Andvacuum was applied at 530 mm Hg for one minute; the sample surface waskept moist by re-applying the slurry every few seconds. After removalfrom the vacuum, any excess solid was gently rinsed away with deionizedwater.

Then an electromagnetic stimulator is connected to an alternatingcurrent power supply. The electromagnetic stimulator consists of a coil.The voltage of the AC power supply is set to 12 volts AC and currentflow through the coil is about four amps. The current is left on and theelectromagnetic stimulator is allowed to bath the dental repair area for3 minutes to cure the slurry. The electromagnetic stimulator increasethe bond strength and promotes the formation of carbonatedhydroxyapatite (HCA).

The patient was asked to rate the pain level of both cleanings and ratedthe level of pain on a 1 to 10 scale for both teeth and the patientrated the pain as a 2.

The then second slurry was applied to the second tooth of the patients.And vacuum was applied at 530 mm Hg for one minute; the sample surfacewas kept moist by re-applying the slurry every few seconds. Afterremoval from the vacuum, any excess solid was gently rinsed away withdeionized water.

Then an electromagnetic stimulator is connected to an alternatingcurrent power supply. The electromagnetic stimulator consists of a coil.The voltage of the AC power supply is set to 12 volts AC and currentflow through the coil is about four amps. The current is left on and theelectromagnetic stimulator is allowed to bath the dental repair area for3 minutes to cure the slurry. The electromagnetic stimulator increasethe bond strength and promotes the formation of carbonatedhydroxyapatite (HCA).

The patient was asked to rate the pain level of both cleanings and ratedthe level of pain on a 1 to 10 scale for both teeth and the patientrated the pain as a 7.

The results of the pain test demonstrated the advantage of the additionof 0.01% by weight of clove oil, 0.03% by weight of Cannabidiol (CBD)oil, 0.02% by weight of Boswellia and 0.001% by weight of chlorotoxinfrom a Blue Scorpion Venom Chlorotoxin, aspirin (ASA) loaded into theethanol by weight equal to 0.05% aspirin to the ethanol.

All publications and patent applications cited in this specification areherein incorporated by reference as if each individual publication orpatent application were specifically and individually indicated to beincorporated by reference. The citation of any publication is for itsdisclosure prior to the filing date and should not be construed as anadmission that the present invention is not entitled to antedate suchpublication by virtue of prior invention.

While this invention has been described with respect to at least oneembodiment, the present invention can be further modified within thespirit and scope of this disclosure. This application is thereforeintended to cover any variations, uses, or adaptations of the inventionusing its general principles. Further, this application is intended tocover such departures from the present disclosure as come within knownor customary practice in the art to which this invention pertains andwhich fall within the limits of the appended claims.

We claim:
 1. A method repairing the dentin of a tooth comprising: usinga nylon brush to produce irregularities in the surface, of dentin;applying a first composition to the cleaned dentin surface; wherein atleast one component of said composition comprises a primer, bioactiveglass substantially lacking silanol groups wherein the glass having amaximum particle size of 1 μm or less, a non-aqueous solvent, dove oil,Cannabidiol oil, Boswellia, an anti-inflammatory agent and pain relieveagent and then using an electromagnetic stimulator to cure and increasebioactivity of said composition and then applying a dental resincomposite to the treated dentin forming a hydroxyapatite on the surfaceof the dentin.
 2. The method of claim 1, wherein said primer is aself-etching primer which is compatible with the dental bonding slurry.3. The primer of claim 2, is an acidic monomer.
 4. The method of claim1, wherein said bioactive glass has the following composition weightpercentage: SiO₂ (44%), Na₂O (23%), CaO (10%), MgO (4.5%), P₂O5 (6%),and CaF₂ (12.5%).
 5. The method of claim 1, wherein said bioactive glasshas the following composition weight percentage: 49.5% SiO₂, 17.0% NaO,26.9% CaO, and 6.6% P₂O₅.
 6. The method of claim 1, wherein saidanti-inflammatory agent is selected from the group consisting ofchlorotoxin from a Blue Scorpion Venom Chlorotoxin, aspirin (ASA) andNSAID
 7. The method of claim 1, wherein said pain relieve is selectedfrom the group consisting of aspirin (ASA) and NSAID
 8. The method ofclaim 1, wherein said non-aqueous solvent is an alcohol.
 9. The methodof claim 8, wherein said alcohol is ethanol.
 10. The method of claim Iwherein the first composition is a slurry.
 11. The method of claim 1wherein the first composition is a gel.
 12. The method of claim 1,wherein said bioactive glass is present at about 0.5% to 40% by weightpercentage of the bioactive glass composition.
 13. A method of preparingexposed dentin of a tooth for bonding to a dental resin composite,comprising: cleaning the exposed dentin with a nylon brush, applying acomposition containing a bioactive glass substantially lacking silanolgroups and said bioactive glass comprises 0.5% to 40% by weightpercentage of said composition; said composition having at least one ofa resin-based adhesive, an acidic monomer primer; a non-aqueous solventcomprising an alcohol, clove oil, Cannabidiol oil, Boswellia, ananti-inflammatory agent and pain reliever and then applying it to theexposed dentin and then using an electromagnetic stimulator to cure saidcomposition.
 14. The method of claim 13, wherein said bioactive glasshas the following composition weight percentage: SiO2 (44%), Na2O (23%),CaO (10%), MgO (4.5%), P2O5 (6%), and CaF2 (12.5%).
 15. The method ofclaim 13, wherein said bioactive glass has the following Compositionweight percentage: 49.5% SiO2, 17.0% NaO, 26.9% CaO, and 6.6% P2O5. 16.The method of claim 13, wherein said anti-inflammatory agent is selectedfrom the group consisting of chlorotoxin from a Blue Scorpion Venom,aspirin (ASA) and NSAID
 17. The method of claim 13, wherein said painrelieve is selected from the group consisting of aspirin (ASA) and NSAID18. The method of claim 13, wherein said alcohol is ethanol.
 19. Themethod of claim 13, wherein the composition is a slurry.
 20. The methodof claim 13 wherein the composition is a gel.